NCT01678144

Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation

Evaluation of the Safety and Performance of the Medtentia Mitral Valve Repair System When Used in Adults Undergoing Mitral Valve Repair Surgery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Medtentia International Ltd Oy · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the trial is to demonstrate the safety and performance of the Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery. In addition, the trial aims to demonstrate that the MAR fulfills the requirements for mitral valve annuloplasty rings.

Detailed description

The purpose of this study is to evaluate the safety and performance of the MAR in patients with mitral regurgitation requiring either isolated mitral valve annuloplasty or mitral valve annuloplasty concomitantly with any of the following, either individually or in combination: * Tricuspid valve repair * Coronary artery bypass grafting (CABG) * Valve resection and chordae repair * Correction of atrial septal defect * Correction of patent foramen ovale * Ablation therapy for atrial defibrillation

Conditions

• Mitral Regurgitation
• Mitral Insufficiency

Interventions

Type	Name	Description
DEVICE	Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)

Timeline

• Start date: 2011-06-30
• Primary completion: 2014-07-30
• Completion: 2016-04-22
• First posted: 2012-09-03
• Last updated: 2019-08-09
• Results posted: 2019-08-09

Locations

1 site across 1 country: Finland